The Netherlands Cancer Institute (NKI) and the National Center for Cancer Immune Therapy, Department of Oncology, of the Copenhagen University Hospital (CCIT-DK) have jointly announced the phase 3 M14TIL trial. The preliminary results of the clinical trial suggest that infusion of autologous in vitro expanded tumour-infiltrating lymphocytes (TILs) improved progression-free survival (PFS) in patients with unresectable or metastatic melanoma.
Melanoma is an aggressive form of skin cancer that can be treated when detected early and present locally (in the skin). In contrast, the metastatic form of the disease is very aggressive and results in high lethality despite currently available treatments. One of the current attractive treatment approaches used in several cancers, including melanoma, is the use of immunotherapies. However, many patients do not derive sizeable benefits from these treatments.
The M14TIL trial is the first clinical study which has compared the treatment benefits of TILs to the standard ipilimumab in anti-PD-1 refractory patients. This phase-3 randomised, the investigator-sponsored clinical trial enrolled 168 patients with unresectable or metastatic melanoma and compared the clinical outcomes with the use of TILs vs standard ipilimumab. The study’s primary endpoint is PFS. The secondary endpoints include PFS according to immune-related response criteria (irRC), overall response rate, complete response rate, overall survival, safety and health technology assessment.
The preliminary results of this study reveal encouraging results with the use of TILs for patients with aggressive melanoma. Primary results from this study will be presented in an upcoming medical meeting.